- Physicians Office Resource

PRIORITYONE Aspiration Catheter
PRIORITYONE - UG1652

Device Description

A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Fragile. Keep dry. Keep away from sunlight.

Device Sizes

Length: 140 Centimeter

Min. Guide Catheter I.D. 2.03Millimeter

Min. Guide Catheter I.D. 0.080Inch

Length: 140 Centimeter
Min. Guide Catheter I.D. 2.03Millimeter
Min. Guide Catheter I.D. 0.080Inch

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DXE

Device Name: Catheter, Embolectomy

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.5150

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 74543334177260

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 54543334177266

Package Quantity: 2

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 54543334177266

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 14543334177268

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 04543334177261

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 14543334177268

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04543334177261

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Unit Box

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